Personal use extracorporeal low intensity shock wave device enhanced user features and functions

ABSTRACT

A device which utilizes low intensity extracorporeal shock therapy for purposes of treating soft tissue damage, cellulite reduction, or erectile dysfunction, to permit a simple, inexpensive, robust, home use solution which permits self-applied treatment for various parts of the user&#39;s body with a form factor, display, information, guidance, tutorials and training, marketing communication and purchase opportunities, viewing angle, timers, annunciators, sound attenuation, and payment options which provide an untrained amateur user with all tools and guidance necessary to properly, effectively, safely and affordably self-administer treatments.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of U.S. ProvisionalApplication Ser. No. 62/903,926, filed Sep. 22, 2019, entitled “PERSONALUSE EXTRACORPOREAL LOW INTENSITY SHOCK WAVE DEVICE ENHANCED USERFEATURES AND FUNCTIONS,” the contents of which are hereby incorporatedby reference as if fully set forth herein.

FIELD OF THE DISCLOSURE

The present disclosure relates to non-invasive home use low intensityshock wave therapy medical devices. More specifically, the presentdisclosure relates to non-invasive home use low intensity shock wavetherapy medical devices for, for example, treating erectile dysfunctionor removing cellulite.

BACKGROUND OF THE DISCLOSURE

Low intensity extracorporeal shock wave treatments are well known in theart and have been widely known and used in the professional medicalcommunity for several decades. The treatment methodology has beendemonstrated to be effective in treating soft tissue injuries or damage,reducing fatty deposits commonly known as cellulite, and most recentlyfor the treatment of male erectile dysfunction.

Conventional devices are intended to be utilized by a trained, skilledprofessional applying the treatment to a third-party patient or subject.Such devices require specific knowledge about human anatomy, treatmentprotocol and regimen, rate of travel of device, pressure to be appliedby device, duration of treatment, and frequency of treatment. Further,the controls and displays of such devices are so positioned as to bevisible and accessible to a third-party professional treatmentspecialist, not to a self-user. Further the cost of such devices may beprohibitively high, rendering the purchase or use of such devices beyondthe means of the average user.

SUMMARY OF THE DISCLOSURE

In at least some examples, a treatment device includes a housing havinga longitudinal axis extending between a proximal end and a distal end, astriking element disposed within the housing and moveable along thelongitudinal axis, a tip disposed adjacent the distal end, and aposition indicator for alerting the user to a proper location on thebody to be treated.

In at least some examples, a treatment device includes a housing havinga longitudinal axis extending between a proximal end and a distal end, astriking element disposed within the housing and moveable along thelongitudinal axis, a tip disposed adjacent the distal end, a processorand a memory.

In at least some examples, a treatment device includes a housing havinga longitudinal axis extending between a proximal end and a distal end, astriking element disposed within the housing and moveable along thelongitudinal axis, a tip disposed adjacent the distal end, and a speedindicator.

BRIEF DESCRIPTION OF DRAWINGS

Various embodiments of the presently disclosed treatment devices aredisclosed herein with reference to the drawings, wherein:

FIG. 1 shows a schematic plan view of one embodiment of the disclosure;

FIG. 2 is a schematic translucent plan view of one embodiment of thedisclosure showing major components used to create and administer lowfrequency shock waves;

FIG. 3 is a schematic side sectional view of one embodiment of thedisclosure; and

FIG. 4 is a schematic closeup sectional side view of one embodiment ofthe disclosure.

Various embodiments of the present disclosure will now be described withreference to the appended drawings. It is to be appreciated that thesedrawings depict only some embodiments of the disclosure and aretherefore not to be considered limiting of its scope.

DETAILED DESCRIPTION

Despite the various improvements that have been made to acoustic wavetreatment devices, conventional devices suffer from some shortcomings.

There therefore is a need for further improvements to the devices,systems, and methods of manufacturing and using acoustic wave treatmentdevices. Among other advantages, the present disclosure may address oneor more of these needs.

As used herein, the term “proximal,” when used in connection with acomponent of a treatment device, refers to the end of the componentfarthest from the treatment area, whereas the term “distal,” when usedin connection with a component of a treatment, refers to the end of thecomponent closest to the treatment area.

Likewise, the terms “trailing” and “leading” are to be taken as relativeto the operator of the treatment device. “Trailing” is to be understoodas relatively closer to the operator, and “leading” is to be understoodas relatively farther away from the operator or closer to the targetsite of treatment.

In conjunction with the included drawings, this detailed description isintended to impart an understanding of the teachings herein and not todefine their metes and bounds. One particular implementation,illustrating aspects of the present teaching, is presented in detailbelow. Some of the many possible variations and versions are alsodescribed.

Conventional devices generally have a form factor that is intended for aprofessional medical provider to administer treatment to a third-partysubject or patient and as such is not ergonomically well suited for anindividual to self-administer treatment. Additionally, there are nodisplays and controls that are readily visible or accessible to anindividual self-administering treatment. Conventional devices also donot provide any information regarding proper positioning of the deviceduring treatment to assist an untrained user in the proper positioningof the device during use.

In contrast, the present disclosure contemplates devices capable ofproviding information regarding proper rate of travel of the deviceduring treatment to assist an untrained user in the proper movement ofthe device during use. The present devices and methods also provideinformation regarding the number of passes completed at any given timeof the device during treatment to assist an untrained user in the properduration of treatment of the device during use. The present device andmethods also monitor and/or limit the operating time of the deviceduring treatment to assist an untrained user in avoiding over-treatmentof the device. For example, the proposed methods and devices may includemonitoring and/or limiting of the total number of operating cycles ofthe device to assist an untrained user in understanding the operationalservice life, and need for periodic maintenance of the device.

The present devices and methods address problems with the limitedviewing angle of the information display of the device which isdetrimental to a self-administering user who must hold the device in avariety of positions and orientations during use, while still needing tosee the displayed information during use. The also address problemsassociated with significant decibel levels of sound produced by thedevice during use which alerts others in proximity to the user that thedevice is in use and thereby prevents the discreet use of the devicesuch as may be desired by a user from time to time.

The devices and methods also may provide communication and/or messagingcapability, which may be useful to communicate additional information tothe user including tutorials, patient tracking, system updates, andmarketing, sales, and/or promotion messaging. The device also providesmeans of remote viewing or imaging which may be useful to communicate toa self-administering user the precise location of the tip during use.The proposed solutions also provide the ability to pay for the deviceand/or operation of the device on a per-treatment basis.

While there are presently a number of proposed solutions to the problemof devices which utilize extracorporeal shock therapy for purposes oftreating soft tissue damage, cellulite reduction, or erectiledysfunction, none has been conceived or implemented to permit a simple,inexpensive, robust, home use solution which permit self-applied lowintensity shock wave treatment for various parts of the user's body witha form factor, display, information, guidance, tutorials and training,marketing communication and purchase opportunities, viewing angle,timers, annunciators, sound attenuation, and payment options whichprovide an untrained amateur user with all tools and guidance necessaryto properly and safely self-administer treatments which would be optimalfor the application.

Low intensity shock wave generation and transfer means embodying theprinciples of this disclosure solve the problems of a simple,inexpensive, robust, home use solution which permit self-applied lowfrequency shock wave treatment for various parts of the user's body witha form factor, display, information, guidance, viewing angle, timers,annunciators, and sound attenuation which provide an untrained amateuruser with all tools and guidance necessary to properly and safelyself-administer treatments for various parts of the user's body as wellas including the capability to display and communicate tutorials,patient tracking, system updates, and marketing, sales, and promotionmessaging. The several embodiments of the disclosure employ designs,materials, and manufacturing methods which are inexpensive andconsistent with current manufacturing practices. The functionality,size, cost, simplicity, ease of use, reliability and robustness of theproposed designs are all advantageous.

Implementations following the principles of this disclosure allow theadvantageous modality of a simple, inexpensive, robust, home usesolution which permit self-applied low frequency shock wave treatmentfor various parts of the user's body with a form factor, display,information, guidance, viewing angle, timers, annunciators, and soundattenuation which provide an untrained amateur user with all tools andguidance necessary to effectively and safely self-administer treatmentsshock wave treatment for various parts of the user's body and have thecapability of delivering tutorials, patient tracking, system updates,and marketing, sales, and/or promotion messaging which would be optimalfor the application.

FIG. 1 shows a plan view of one embodiment of the device 100 extendingbetween proximal end 102 and distal end 104. Device 100 includes ahousing 126 in the form of an elongated, generally cylindrical bodywhich is easily and conveniently grasped in the user's hand in such amanner as to advantageously permit the user to accurately place tip 1 onthe desired area of the body to apply treatment. Display 125 isadvantageously positioned so as to permit an unobstructed line of sitefor the viewer from the proximal end 102 toward the distal end 104during most normal usage. End cap or nose cone 128 is easily accessibleand removably attached to housing 126 by any of a variety ofconventional means including an internal screw thread, an interruptedthread, a snap lock or any of a variety of mechanical fasteners, so asto facilitate the simple installation, removal, replacement, orswitching of tip 110 as required for the selected treatment. In oneembodiment, nose cone 128 is secured to housing 126 by an interruptedthread which requires no tools and only a partial rotation to remove andreplace. Bar graph segments 173 are readily viewed by the user when thedevice is positioned and held for use; and annunciator LEDs 172 are alsoreadily seen during use of device 100.

Still referring to FIG. 1 , smartphone 151 may be seen to be inproximity to device 100 and may be in communication with the device 100.In at least some examples, smartphone 151 may be wirelessly dataconnected to device 100 by means of a communication module, for exampleBluetooth or any of a variety of other wireless data connection meansand protocols, for purposes of wirelessly communicating with device 100.It is through such communication of smartphone 151 with device 100, morespecifically with printed circuit board 134 and the electroniccomponents situated thereon including microprocessors and othersemi-conductors and a memory, that a bi-lateral communication means maybe established between device 100 and smartphone 151. This bi-lateralcommunication means may be advantageously utilized for communication,display, control, monitoring, and/or marketing functions.

Given that smartphone 151 is able to communicate wirelessly with device100, it may be utilized to perform several functions which areadvantageous for the user. First, it may serve as the control panel andinformation display for device 100. This is advantageous for severalreasons. First, smartphone 151 likely has a touch screen and large colordisplay which enable a very high-quality graphical user interface whichmay variably and preferentially display information and/or controls asneeded. Smartphone 151 may also advantageously be placed in a locationwhich is optimal for the user to see displayed information and interactwith controls to turn the device 100 on and off, or stop and startoperation of the device 100.

Given that smartphone 151 is capable of internet enabled communication,it may be used to provide any of the following: tutorial and coachinginformation to the user including ‘how-to’ videos prior to or duringuse, usage tips; health, diet, exercise, and lifestyle tips to maximizeresults; and sales and marketing opportunities to purchase consumables,upgrade or purchase additional units, purchase spare parts; and sociallinks to connect the user with user groups, community bulletin boards,and other social media resources including potentially dating sites,clubs, organizations, and groups. Smartphone 151 may also be utilized tokeep track of treatments, results, user progress, and provide remindersabout upcoming treatments or recommended ancillary treatments orproducts. Further, smartphone 151 may provide user access to frequentlyasked question resources and potentially also to live chat or humanoperators for additional assistance.

In some examples, device 100 may be deployed on parts of the user's bodywhich are difficult to see with direct line of site for example when thedevice is being used to reduce cellulite on the buttocks or back of thethigh, yet which are important to visually monitor during use, device100 may be equipped with a camera 174 which may be of a closed circuit,webcam or any of a wide variety of other cameras well known in the art,so located proximal to the nose cone 128 of device 100 by which means itprovides a field of view including tip 110 of device 100 and thetreatment area of the user, which can communicate the image data withsmartphone 151 which displays it, thereby enabling the user to see wheretip 110 of device 100 is being placed during use.

In some examples, smartphone 151 is capable of internet enabledcommunication and e-commerce functions with a remote server, and it mayserve as the secure communication, monitoring, and payment portalthrough which a fundamentally new model of service may be enabled—a ‘payper pulse’ or ‘pay as you go’ model wherein device 100 is sold at a verylow cost, or given at no cost to the end user, but will not operateuntil activated. Activation is accomplished by means of an applicationor ‘app’ which is downloaded and installed on the user's smartphone 151,and which by means of secure and/or encrypted wireless communicationwith device 100 permits the user to purchase by means of e-commerce orany of a wide range of well-known transaction means activationpermission for the device 100 which activation permission is quantifiedby treatment duration or intensity, number of pulses of operation, orduration of use, or by any other delimiting factor deemed necessary ordesirable. Once a purchase has been made in-app, the user's smartphone151 communicates securely with device 100 by means of the aforementionedsecure wireless communications link and authorizes device 100 to operateat the user's discretion to the limit of the purchased activationpermission. By this means, two of the greatest obstacles to thecommercial sale of this device are overcome: first, the initial purchaseprice, which may be dramatically lower than would be the case for adevice which did not require purchase of activation permission which isessentially a means of spreading the total cost of purchase andoperation over time; and second, the concern that the device will noperform as promised or will not for any of a variety of reasons beacceptable or desirable for the purchaser and in the event that thedevice was purchased at full price without the requirement of activationpermissions, there is a far greater risk of financial loss for thepurchaser if they elect not to utilize the device after purchase. Theactivation permission model essentially distributes the risk far morefavorably for the purchaser.

Still referring to FIG. 1 , it may be seen how several of the controland display features including alphanumeric display 125, annunciatorLEDs 172, and LED bar graph 173 advantageously communicate criticaloperational status and tutorial information to the user as follows:

Upon power up by means of on/off switch 159, alphanumeric display 125,annunciator LEDs 172, and LED bar graph 173 are illuminated. Thisindicates that device 100 has been energized and is ready for use andoperation. Given that device 100 is intended for use by a user who mostlikely has no special training or medical knowledge, one of theprincipal challenges, which has been met by one of the inventive stepsdisclosed herein, is the means by which an untrained user may safely andeffectively self-administer treatment with the device. The firstchallenge for the untrained user is to understand which line of travelto follow with tip 110 of device 100. In the instance that device 100 isbeing used to treat erectile dysfunction, the treatment protocolspecifies 5 lines of travel longitudinally along the user's penis. Theselines of travel are along the top centerline, and along the upper andlower sides of the penis as most readily communicated by calling themout as positions on a clock face—for example 12 o'clock is the topcenterline, 2 o'clock is the upper left side line of travel, etc. Tothis end, annunciator LEDs 172 are so arranged and oriented on device100 as to provide a simple and unambiguous guide to the user indicatingwhich line of travel is to be treated, which has already been treated,and which has not yet received treatment. To facilitate the user knowingwhich line of travel is being called for at each stage of the treatment,annunciator LEDs 172 may exhibit one of 3 states when device 100 isenergized. In the unilluminated state, the LED remains off and no coloris displayed. This indicates that the corresponding line of travel hasnot yet been treated. If annunciator LED 172 is illuminated green, thisindicates that this particular line of travel is currently beingtreated, indicating that this is the line of travel upon which tip 110of device 100 is to be placed. Once treatment along this line of travelhas been completed, annunciator LED 172 changes to red illuminationcolor. This indicates that treatment for this line of travel has beencompleted. To further illustrate the point, upon initial power-up ofdevice 100, all annunciator LEDs 172 are off, except the line of travelwhich is to receive the first treatment, which will be illuminatedgreen. Upon completion of 4 lines of treatment, 4 annunciator LEDs 172will be illuminated red, and the annunciator LED 172 indicating thefinal line of treatment will be illuminated green.

In order that the user has time to place tip 110 of device 100 on theappropriate line of travel and to prepare to administer the treatment,device 100 is energized upon switching on of on/off switch 159 coupledto a power source (e.g., battery or plug), but it does not beginoperating or generating energy waves for treatment. Once device 100 isin position, the user presses momentary start button 171 to activate thedevice 100. Upon activation, device 100 begins emitting sound waves fromtip 110, for treating the target treatment area.

Still referring to FIG. 1 , it may be plainly seen how LED bar graph 173is advantageously positioned to be visible to the user during operationof device 100. The function of LED bar graph 173 is to provide the userwith visual guidance for the rate of travel of tip 110 of device 100across the treatment area. Bar graph 173 eliminates the need for thedevice to be operated by skilled, trained medical professionals.Instead, bar graph 173 allows for operation by an unskilled user, andreduce or eliminate the risk of physical injury as a result of improperuse. The single greatest risk to the user is the administration of anexcessive number of sound wave pulses to any one area of soft tissue.Low intensity shock wave devices are intended to be in constant motionalong a treatment path of travel, rather than remaining in one locationfor a period of time. A second risk to the user is that of reducedefficacy of treatment because the rate of travel of tip 110 is too fast.To safeguard against both eventualities and to make device 100 moresafely and effectively operated and self-deployed by an untrained user,the inventive step of a pacing LED bar graph 173 has been incorporatedin device 100 to provide an analogue visual reference guide for the rateof travel of tip 110 along the designated treatment path. The 10emissive elements of LED bar graph 173 begin all illuminated uponinitial energizing of device 100. One LED however, either in position 1or position 10 will not be steadily illuminated, but will instead beflashing. By this means, the user will know upon which end of the lineof travel to place tip 110 and thereby upon which end of the line oftravel to begin treatment.

As treatment begins, the user moves tip 110 of device 100 along the lineof treatment. The rate of travel is likely something an untrained userhas no awareness of and conventional means of quantifying a rate oftravel are difficult to comprehend and difficult to translate intooperation for an untrained, unskilled user; yet proper rate of travel oftip 110 of device 100 is crucial to the safety and efficacy of thedevice. To this end, LED bar graph 173 begins decrementing immediatelyupon treatment initiation once momentary start button 171 has beendepressed. Decrementing is accomplished by turning off each successiveLED in LED bar graph 173 after one tenth of the treatment time durationfor a single line of travel has elapsed. For example, if the duration oftreatment for one pass on one line of treatment travel is 10 seconds,one LED of LED bar graph 173 will extinguish illumination each second,in succession. By this means, the user will be able to visually equatethe percentage of the line of treatment which has been treated as wellas the percentage of the line of treatment remaining to be treated withthe percentage of LEDs extinguished and illuminated respectively. Forexample, the user will readily comprehend that when the first 5 LEDs areextinguished, and the next 5 LEDs remain illuminated, the tip 110 ofdevice 100 should be halfway along the line of treatment, such that theline of treatment will be completed and the tip 110 of device 100 willbe at the terminus point of the line of treatment concurrent with theextinguishment of the final LED, number 10. By this means, the user isable to perform a safe and effective treatment based on a proper rate oftravel along each line of treatment.

Upon completion of one pass of device 100 along a line of travel oftreatment, LED bar graph 173 once again illuminates all emissiveelements, with all elements illuminated steadily, except for the lastLED which blinks, indicating that this is the end of the line of travelat which the next treatment pass will begin. The LEDs will now beginsuccessively extinguishing, once again providing a proportional visualanalog for the user to properly gauge the position and rate of travel ofdevice 100 at any point in the treatment cycle.

Still referring to FIG. 1 , we now discuss the function of alphanumericdisplay 125. Upon initial energization of device 100, alphanumericdisplay 125 will display the total number of passes required for thefirst line of treatment travel. In the event that the treatment protocolcalls for 10 passes on each line of treatment, alphanumeric display 125will initially display the number 10. Upon activation of device 100 bypressing momentary start button 171, and the initiation of one passalong the line of treatment travel by the user, alphanumeric display 125will continue to display the number of passes for the current line oftravel, until such time as the device reaches the terminus point of theline of travel as indicated by the extinguishment of all segments of LEDbar graph 173, at which point the alphanumeric display 125 willdecrement one count, in this case now display “9” indicating that 9passes remain on this treatment cycle for this line of travel.Alphanumeric display 125 will continue to decrement until the full countof passes per the treatment protocol has been executed. At this time,device 100 will be de-activated, meaning it ceases producing sonicwaves, and concurrently the annunciator LED 172 for the just competedline of travel will change in illumination from green to red and thenext indicated line of travel annunciator LED 172 will illuminate greenindicating that the user should reposition tip 110 of device 100 on theindicated line of travel and prepare to initiate another phase of thetreatment. By this means, even the unskilled user may perform a safe andeffective treatment with proper positioning of lines of travel, properrate of travel of device 100 and proper counts for passes along eachline of travel. It is anticipated that each of the aforementionedvariables including duration of treatment per pass along a line oftravel, number and location of lines of travel, rate of travel, andnumber of passes along each line of travel may be altered or varieddepending on the treatment type and patient needs, and may be alteredinteractively in the case that device 100 is coupled to the internet bymeans of smartphone or some other means of connectivity well known inthe art.

Upon completion of a complete course of treatment comprising theprescribed number of passes along each line of treatment travel for allprescribed lines of treatment travel, the device will go into a sleepmode wherein it will not operate for a prescribed period of time,perhaps 36 hours or 72 hours or 96 hours. The purpose of this timeoutfunction is to prevent over-use by an overly enthusiastic user lackingmedical knowledge or training, thereby not understanding that excessiveuse will not only not yield greater results buy may actually be harmfulor dangerous. By this means, yet another inventive step, the untraineduser is once again limited to a prescribed course of treatment which issafe and effective.

Alphanumeric display 125 may be utilized to display the number of hoursremaining in the time out mode until operation of the device may resume.

A further software resident operating limitation may dictate totaloperational life of the device wherein after a certain total cumulativenumber of pulses the unit enters a ‘sunset’ mode where it will no longeroperate. Conversely, it may simply give a visual indication on thealphanumeric display 125 or some such other display that the unit hasreached the end of its design life and requires service or replacement.The purpose of this feature is to safeguard against the continued usageof the device beyond the design life, after which the energy signaturemay be compromised due to the excessive wear or failure of high stresscomponents within the device responsible for generating the shock wave.

Referring now to FIG. 2 which is a translucent plan view of oneembodiment of the disclosure, the arrangement of certain majorcomponents may be plainly seen including the placement and location ofprinted circuit board 134 advantageously positioned to support theaforementioned controls and displays, and also incorporating blue toothcommunication integrated circuit 175 and audio processor/amplifier 169.

Referring now to FIG. 3 which is side section view of one embodiment ofthe device, it may be plainly seen how major components of the assemblyare arranged and interact with one another, particularly driveshaft 115,transfer slug 162, and tip 110. In this view it may be seen howcompression spring 116 is compressed by cam follower 114 riding theramps of helical cam 113 until such time as cam follower 114 falls offof cam toe 160 thereby precipitously releasing the stored energy incompression spring 116 which causes driveshaft 115 to rapidly acceleratetowards transfer slug 162. Further, it may be understood how driveshaft115 collides with transfer slug 162 with great velocity and kineticenergy, and as a result of this collision transfer slug 162 collideswith tip 110 with similarly great velocity and kinetic energy. Theserepeated collisions which in the preferred embodiment of device 100occur 15 times per second create a high decibel sound which may beproblematic for users for several reasons. First, the sheer decibellevel and frequency of the sound may be painful to listen to andpotentially harmful to the hearing of anyone in close proximity, therebyrequiring hearing protection during operation of the device 100; andsecond, in some instances a user desires discretion during use of thedevice 100 so as not to alert others in close proximity to the fact oftheir utilization of the device. For both of these reasons it may bedesirable to significantly reduce the decibel level of the operationnoise created by the device 100.

While certain materials and design practices well known in the art maybe employed to attenuate these sounds passively, it may be desirable tofurther attenuate sound levels beyond that which may be accomplished bysuch means. To this end, it may be desirable to employ a noisemitigation technique known as active noise cancelling.

Referring now to FIG. 4 which is a close up side section view of theproximal end of the preferred embodiment of the device, it may be moreplainly seen how driveshaft 115, transfer slug 162 and tip 110 interactwith one another and collide inelastically to transfer energy from theinitial storage source of compression spring 116 to driveshaft 115, totransfer slug 162, to tip 110 and thereby to the treatment area of theuser. Active noise cancellation which is well known in the art has neverbeen applied to a low intensity shock wave device. Such devices areparticularly well suited to sound attenuation by active noisecancellation given that active noise cancellation works best in anenvironment where the objectionable sounds are consistent, fixed,predictable, and occurring at regular intervals—essentially preciselythe operating conditions of device 100.

Still referring to FIG. 4 , it may be seen how microphone 168 is sopositioned and located as to be able to monitor the sound energy createdby the collision of driveshaft 115 with transfer slug 162, and withtransfer slug 162 and tip 110. The monitored signal is transmitted toaudio processor/amplifier 169 on printed circuit board 134, both visiblein FIG. 2 . Audio processor/amplifier 169 analyzes the signal receivedfrom microphone 168 and generates an identical audio signal which isphase shifted one half phase in order to effectively cancel the soundemanating from the device. The amplified phase shifted signal istransmitted to speaker 170 which may be a standard cone and voice coil,piezo electric or any of a variety of other speaker types well known inthe art and which may actually be multiple speakers strategicallylocated so as to optimally cancel the offensive original generated noisefrom device 100, said speaker emitting a phase shifted mimic of theoriginal detected sound which will in large part cancel the overallsound of the device, and by this means render the device much quieterfor safe, discreet operation.

It may be seen in these several embodiments of the disclosure that thedisclosure overcomes the deficiencies of all previous attempts atsolving the problem of device which administers low intensity shockwaves to targeted areas of the user's body for treatment of soft tissuedamage, cellulite reduction, or erectile dysfunction which is a safe,inexpensive, self-applied, home use solution which does not require asecond person to operate, significant medical or anatomical knowledge,special training, and which provide for tutorials, patient tracking,system updates, and marketed, sales, and promotion capabilities, whichwould be optimal for the application.

In broad embodiment, the present disclosure is a device whichadministers low frequency shock waves to targeted areas of the user'sbody for treatment of soft tissue damage, cellulite reduction, orerectile dysfunction which is a safe, inexpensive, self-applied, homeuse solution which does not require a second person to operate,significant medical or anatomical knowledge, special training, and whichprovide for tutorials, patient tracking, system updates, and marketing,sales, and promotion capabilities, and reduced noise, which would beoptimal for the application.

While the foregoing written description of the disclosure enables one ofordinary skill to make and use what is considered presently to be thebest mode thereof, those of ordinary skill will understand andappreciate the existence of variations, combinations, and equivalents ofthe specific embodiment, method, and examples herein. The disclosureshould therefore not be limited by the above described embodiment,method, and examples, but by all embodiments and methods within thescope and spirit of the disclosure as claimed.

The invention claimed is:
 1. A treatment device comprising: a housinghaving a longitudinal axis extending between a proximal end and a distalend; a striking element disposed within the housing and configured tomove along the longitudinal axis; a tip disposed adjacent the distalend; and a position indicator configured to alert the user to a properlocation on the body to be treated, wherein the position indicatorincludes a plurality of lights, each of the plurality of lightsindicating a line of travel along a body part.
 2. The treatment deviceof claim 1, wherein the plurality of lights includes five lightscorresponding to five lines of travel.
 3. The treatment device of claim1, wherein the plurality of lights are arranged in a circle, each of theplurality of lights corresponds to the location on the body asrepresented on a clockface.
 4. The treatment device of claim 1, whereineach of the plurality of lights includes an LED light configured tosignify three conditions including an untreated condition, anin-treatment condition, and a treated condition.
 5. The treatment deviceof claim 4, wherein each LED light is configured to be unilluminated tosignify an untreated condition, to be illuminate green to signify anin-treatment condition, and to illuminate red to signify a treatedcondition.
 6. The treatment device of claim 1, further comprising adisplay disposed adjacent the distal end of the housing.
 7. Thetreatment device of claim 6, wherein the display is configured toindicate the number of treatments to be performed on each line oftravel.
 8. A treatment device comprising: a housing having alongitudinal axis extending between a proximal end and a distal end; astriking element disposed within the housing and configured to movealong the longitudinal axis; a tip disposed adjacent the distal end; aprocessor configured to shut off the treatment device for apredetermined period of time after a treatment; and a memory.
 9. Thetreatment device of claim 8, wherein the processor is configured tocount a number of pulses.
 10. The treatment device of claim 8, whereinthe processor is configured to shut off the treatment device for between72 and 96 hours after the treatment.
 11. The treatment device of claim8, wherein the processor is configured to shut off the treatment devicepermanently after a predetermined number of treatments.